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Clinical Trial of Concomitant Hip Arthroscopy During PAO

Primary Purpose

Hip Dysplasia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Periacetabular osteotomy
Periacetabular osteotomy with hip arthroscopy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Dysplasia

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of hip dysplasia (DDH) electing periacetabular osteotomy (PAO) for treatment
  • Skeletally mature
  • Age 15 - 55
  • Tonnis Grade 0 or 1 osteoarthritis (minimal or no arthritis)
  • Ability to receive a standard of care preoperative (magnetic resonance imaging) MRI arthrogram of the hip

Exclusion Criteria:

  • Pregnant women
  • Previous surgery about the hip
  • Patients receiving PAO for acetabular retroversion in the absence of DDH
  • Previous hip arthroscopy to address intra-articular pathology

Sites / Locations

  • Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Periacetabular osteotomy

Periacetabular osteotomy with hip arthroscopy

Arm Description

Standard periacetabular osteotomy on the day of surgery.

Hip arthroscopy on the day of surgery, followed by a standard periacetabular osteotomy.

Outcomes

Primary Outcome Measures

Mean score of Hip Disability and Osteoarthritis Outcome (Hoos)
Score ranges from 0-100 with higher scores representing better function.
Mean score of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The scores range from 0-4 in 24 different categories that are broken up into three subcategories: pain, stiffness and physical function.
Mean score of University California Los Angeles (UCLA) activity assessment
Measured on a 1-10 scale: 1) wholly inactive, dependent on others; 2) mostly inactive, restricted to minimal activities of daily living; 3) sometimes participate in mild activities such as walking, limited housework, or shopping; 4) regularly participate in mild activities; 5) sometimes participate in moderate activities such as swimming and unlimited housework or shopping; 6) regularly participate in moderate activities; 7) regularly participate in active events such as bicycling; 8) regularly participate in very active events such as bowling or golf; 9) sometimes participate in impact sports such as jogging, tennis, or skiing, or heavy labor; and 10) regularly participate in impact sports.
Mean score of the Marx Activity Scale (MARX)
Score is measured from 0-4.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2017
Last Updated
August 26, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03181048
Brief Title
Clinical Trial of Concomitant Hip Arthroscopy During PAO
Official Title
Single-Blind Randomized Clinical Trial of Concomitant Hip Arthroscopy During Periacetabular Osteotomy for the Management of Hip Dysplasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will assess the outcomes of patients treated with concomitant hip arthroscopy at the time of periacetabular osteotomy (PAO) for patients with hip dysplasia compared with patients treated with PAO alone.
Detailed Description
There are currently no absolute indications for intraarticular assessment at the time of periacetabular osteotomy (PAO). Based on investigators' review of the literature and experience, patients who may benefit from intraarticular assessment are those with radiographic or MRI evidence of damage where an intraarticular inspection may help in determining whether a PAO is a reasonable procedure, those with mechanical symptoms likely related to labral pathology, round ligament or cartilage problems and those with hip dysplasia and cam deformities with limited range of motion that may benefit from femoral head neck junction osteochondroplasty. However, despite these relative indications today there is no clear evidence to suggest that these patients will do better than those that do not have intraarticular work done. Hence, the objective of this project is to determine whether intraarticular work at the time of PAO surgery leads to improved pain and function when compared to patients that do not undergo intraarticular work at the time of PAO.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients will be randomized in a 1:1 fashion. The first arm will be the "PAO alone" group who will receive a standard periacetabular osteotomy (PAO) on the day of surgery. The second arm will be the "PAO + HA" group who will receive a PAO and hip arthroscopy (HA) on the day of surgery. Any pathology if present that can be corrected with the arthroscope (cartilage and labral abnormalities) will be addressed. This will be followed by a standard PAO. Patients from both groups will have dressings placed in the location of hip arthroscopy portals to remain blinded to the treatment arm during the perioperative period. Only patients in the PAO + HA group will have incisions and sutures under these dressings. The dressings will come off for all patients after 2 weeks, which is standard of care. All other study team members will remain unblinded.
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Periacetabular osteotomy
Arm Type
Experimental
Arm Description
Standard periacetabular osteotomy on the day of surgery.
Arm Title
Periacetabular osteotomy with hip arthroscopy
Arm Type
Active Comparator
Arm Description
Hip arthroscopy on the day of surgery, followed by a standard periacetabular osteotomy.
Intervention Type
Procedure
Intervention Name(s)
Periacetabular osteotomy
Intervention Description
The Bernese periacetabular osteotomy has become the osteotomy of choice in North America for correction of the dysplastic hip. The ability to position the acetabular component in a specifically desired position for each individual patient improves joint biomechanics, restores joint balance and stability, and offloads the structures at risk for damage such as the labrum and the adjacent articular cartilage.
Intervention Type
Procedure
Intervention Name(s)
Periacetabular osteotomy with hip arthroscopy
Intervention Description
An intraarticular assessment with hip arthroscopy (HA) at the time of periacetabular osteotomy allows the surgeon to assess and treat the associated labral and chondral pathology and allows the surgeon to treat abnormalities of the femoral head junction.
Primary Outcome Measure Information:
Title
Mean score of Hip Disability and Osteoarthritis Outcome (Hoos)
Description
Score ranges from 0-100 with higher scores representing better function.
Time Frame
1 year follow-up time point
Title
Mean score of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
The scores range from 0-4 in 24 different categories that are broken up into three subcategories: pain, stiffness and physical function.
Time Frame
1 year follow-up time point
Title
Mean score of University California Los Angeles (UCLA) activity assessment
Description
Measured on a 1-10 scale: 1) wholly inactive, dependent on others; 2) mostly inactive, restricted to minimal activities of daily living; 3) sometimes participate in mild activities such as walking, limited housework, or shopping; 4) regularly participate in mild activities; 5) sometimes participate in moderate activities such as swimming and unlimited housework or shopping; 6) regularly participate in moderate activities; 7) regularly participate in active events such as bicycling; 8) regularly participate in very active events such as bowling or golf; 9) sometimes participate in impact sports such as jogging, tennis, or skiing, or heavy labor; and 10) regularly participate in impact sports.
Time Frame
1 year follow-up time point
Title
Mean score of the Marx Activity Scale (MARX)
Description
Score is measured from 0-4.
Time Frame
1 year follow-up time point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of hip dysplasia (DDH) electing periacetabular osteotomy (PAO) for treatment Skeletally mature Age 15 - 55 Tonnis Grade 0 or 1 osteoarthritis (minimal or no arthritis) Ability to receive a standard of care preoperative (magnetic resonance imaging) MRI arthrogram of the hip Exclusion Criteria: Pregnant women Previous surgery about the hip Patients receiving PAO for acetabular retroversion in the absence of DDH Previous hip arthroscopy to address intra-articular pathology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cody Wyles, MD
Phone
(507) 284-1175
Email
wyles.cody@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Cole
Phone
507-266-1227
Email
cole.lauren@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Sierra, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cody Wyles, MD
Phone
507-284-1175
Email
wyles.cody@mayo.edu
First Name & Middle Initial & Last Name & Degree
Rafael Sierra, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only study personnel authorized by the investigator will collect data/enroll subjects. Data will be stored in electronic files and/or a cabinet, with access to study personnel as authorized by the investigator. The investigator will review the data on a regular basis (at least annually) to verify the validity of the data.
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Clinical Trial of Concomitant Hip Arthroscopy During PAO

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